FDA WARNING_LETTER - bull frog fish farm, llc. - September 14, 2010

The FDA inspected Bullfrog Fish Farm, LLC dba Bullfrog Fish Farm Eat My Fish in Menomonie, Wisconsin, on multiple dates in August and September 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110).

The firm's smoked trout products are deemed adulterated due to insanitary conditions, and both Smoked Trout and Smoked Trout Spread products are misbranded. Key violations include: 1. **HACCP Plan Deficiencies:** The Smoked Trout Spread HACCP plan failed to list undeclared allergens as a food safety hazard. 2. **Inadequate Monitoring Frequency:** The Smoked Trout Spread HACCP plan's monitoring frequency for storage was insufficient to control pathogen growth. 3. **Lack of Record Keeping System:** Both Smoked Trout Spread and Smoked Trout HACCP plans lacked a record-keeping system for critical control points. 4. **Verification Failure:** The firm did not calibrate its continuous monitoring device, leading to discrepancies in smoking temperature logs. 5. **Failure to Implement Monitoring:** Smoking records showed the firm did not follow the required monitoring frequency at the smoking critical control point. 6. **Sanitation Violations:** The firm failed to monitor sanitation conditions, evidenced by: